Event Description It was reported that during the patient's initial implant surgery on (b)(6) 2014, there were difficulties identifying the nerve due to a structure with a similar appearance. Therefore, following placement of the electrodes on the structure believed to be the vagus nerve, the patient¿s generator was programmed on (output current - 2ma) in an attempt to induce bradycardia and therefore identify if the electrodes were indeed on the vagus nerve. Bradycardia was observed as intended and resolved without intervention. Therefore, it was concluded that the electrodes were properly placed. The generator was inadvertently not programmed off after the tests were completed due to communication difficulties with the programming system. As a result, the patient experienced painful stimulation, neck muscle spasms, and severe coughing until the surgeon programmed the patient's generator off and administered morphine the following day.

Event Description It was reported that a patient's device was showing high impedance. The patient was sent for x-rays of her neck and chest. The device settings were lowered and it was stated that the device was not bothering her after that; so the device was not turned off during the visit. Further updates were received noting additional diagnostics performed on the patient's device. Two diagnostics were performed confirming the high impedance. It was stated that the device was intended to be turned off due to painful stimulation in the neck. The patient had also reported that her neck locks up at times to the left side. After device settings were adjusted, the patient was concerned that fully disabling her device would lead to increased seizures, so the settings were kept at the lower output. The patient reported no longer feeling pain with the new settings. No additional relevant information was received to date.

Event Description The patient reported experiencing an increase in seizures and painful stimulation. Further information was received that the patient is referred for replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

Model Number 105Device Problem Adverse Event Without Identified Device or Use Problem Event Date 11/06/2018Event Type Injury Event Description The patient reported that they experienced an increase in seizure frequency due to the low battery of the generator. The physician attributed the patient's increase in seizure frequency to battery depletion. Per the physician, the patient also indicated that she experienced pain, with and without stimulation, all over her body that worsened with stimulation. The patient stated that the pain was due to the low battery of the generator as well. The physician indicated that the patient was referred for generator replacement due to patient comfort. The manufacturer's battery life estimation tool was unable to verify battery depletion based on the available patient programming data. No relevant surgical intervention has occurred to date. No further relevant information has been received to date.

Model Number 105Event Date 02/25/2014Event Type Injury Event Description Clinic notes were received for the vns patient¿s neurosurgery consultation on (b)(6) 2014. The notes indicate that the patient was experiencing a recent increase in seizures along with a shocking sensation at the generator site; therefore, the patient was admitted to the hospital through the emergency room on (b)(6) 2014. The patient stated that his seizure frequency had increased from five seizures a day to a seizure every hour. The baseline seizures appeared to last approximately 15 seconds and were tonic-clonic or absence seizures. Radiology reported that neck x-rays showed that lead wires were ¿off. ¿ chest x-rays were reported to be unremarkable. Operative notes were received stating that the patient underwent generator and lead replacement surgery on (b)(6) 2014. The notes indicate that the patient was experiencing a shocking sensation in his neck with stimulation. Imaging revealed abnormal placement of the lead electrodes. The generator was replaced during the procedure as it was nearing end of service. An implant card was received stating that the lead was replaced due to lead discontinuity. Diagnostic results with the replacement generator and lead revealed lead impedance within normal limits (impedance value ¿ 1906 ohms). Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Attempts for additional relevant information were made, but have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description Analysis of the returned generator and lead was completed. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed high impedance never occurred. Analysis of the returned lead portion found abraded openings on the outer silicone tubing which most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Manufacturer Narrative Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death.

Model Number 105Event Date 01/01/2014Event Type Injury Event Description It was reported that the patient was hospitalized for an increase in seizures that began the week prior. It was reported that the patient has experienced about 60 seizures over the past week. It is unknown if the increase in seizures was above the patient's pre-vns baseline frequency. It was reported that the patient was also experiencing painful stimulation at the electrode site that improves with pressure applied to the site. The physician decreased the patient's settings; however, this did not resolve the patient's pain. The device was later disabled. It was reported that device diagnostics were within normal limits (1326 ohms). The physician reported that he wanted to prophylactically replace the lead since it is 10 years old. X-rays were taken, but the results were not provided to manufacturer. It was reported that despite the diagnostics being within normal limits the physician still believes the painful stimulation and increase in seizures are due to a lead issue. It was reported that there was no trauma, medication changes or other recent changes that could have causes the increase in seizures and painful stimulation. Further follow-up revealed that the patient was airlifted to a hospital in a bigger city and it was decided to not replace the patient's lead. The patient's medication was adjusted and the vns was programmed back on and ramped up to 1ma output current. The physicians would not provide any additional information.

Model Number 105Event Date 01/25/2014Event Type Injury Manufacturer Narrative Review of the available programming and diagnostic history.

Event Description It was reported that the vns patient began experiencing pain at the electrode site on the left side of her face and neck on (b)(6) 2014. Additionally, the patient had difficulty chewing during stimulation. According to the neurologist, the relationship between the reported pain and vns is increased sensitivity to vns stimulation due to unknown etiology. The pain appeared to occur with stimulation. To preclude a serious injury, the neurologist lowered the patient¿s programmed settings. Product information is not available due to hospital policy. The available programming history did include any diagnostic results.

Model Number 103Event Date 10/01/2013Event Type Injury Event Description It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. Additional information was received stating the neck pain was the reason for the replacement surgery. The patient began experiencing the pain around (b)(6) 2013. The pain occurred with stimulation and ceased when the magnet was used to disable the device. Diagnostic results revealed lead impedance to be within normal limits (impedance value ¿ 3114 ohms). Causal or contributory programming or medication changes did not precede the onset of the pain. The epileptologist stated that a thyroid lesion may have contributed to the pain. The pain resolved when the device was programmed off and did not recur when the replacement device was programmed on. Attempts for product return have been unsuccessful.

Manufacturer Narrative Date received by manufacturer; corrected data: the date received by manufacturer was incorrectly reported on the initial manufacturer report. The date should have been (b)(4) 2014.

Model Number 302-20Event Date 02/01/2014Event Type Malfunction Manufacturer Narrative Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description It was reported that the patient needs a lead replacement because the lead is "malfunctioning". It was reported that the patient went through a metal detector and now the lead is "malfunctioning". Clinic notes dated (b)(6) 2014 note that the patient went through a metal detector on (b)(6) 2014 and after that the patient experienced some vague soreness which intensified into severe pain on (b)(6) 2014. The patient described the pain as burning in the neck/chest area. It was noted that the magnet was placed over the generator with no improvement, but gradually subsided. It was noted that the patient still feels very sore and there was no trauma to the neck and no infectious symptoms. The device output current was decreased and the pulse width increased. The notes indicate that the patient will be referred to surgery. The surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. The physician reported that x-rays were taken, but will not be sent to manufacturer for review. The pain was reported to be with device stimulation. The patient underwent generator and lead replacement on 02/14/2014. An implant card was received that indicated that the patient underwent generator and lead replacement due to "adverse event - pain in left neck". The generator and lead were returned for analysis. Analysis of the generator was completed on (b)(4) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.

Manufacturer Narrative The initial mfr. Report stated "the surgeon reported that the patient experienced a significant amount of scar tissue when the current lead was implanted. " this sentence is being corrected to "the surgeon reported that in the lead revision in 2011 that there was a significant amount of scar tissue but was able to remove the electrodes from the nerve and replace with the new (current) lead. " device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description Analysis of the lead was completed on 03/17/2014. Note that a portion of the lead assembly including the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 43mm portion quadfilar coil 1 appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and evidence of a stress induced fracture (torsional appearance) on two of the broken coil strands, which most likely completed the fracture. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Model Number 302-20Event Date 02/01/2014Event Type Malfunction Event Description An implant card was received indicating that the patient underwent generator and lead replacement due to lead discontinuity and battery depletion. It was reported that the explanted devices were sent to pathology and disposed of. No product analysis can be performed.

Event Description It was reported that x-rays were performed because the patient's device was not working. X-rays were sent to manufacturer for review. Review of the x-rays did not identify any obvious discontinuities with the vns system; however, the presence of a microfracture could not be ruled out. Further follow-up with the physician identified that high impedance (dc dc code - 7) was observed. It was reported that the patient had complained of discomfort and burning at the back of the throat. It was reported that device frequency was reduced from 25hz to 20hz for the discomfort. The patient reported that the discomfort and burning began approximately two months prior and occurs with device stimulation. The patient mentioned that the pain and burning worsens when moving the head from side to side. The patient denied and trauma that may have caused or contributed to the high impedance. The physician reported that the device was programmed off and the patient would be referred for surgical consult. No surgical intervention has been performed to date.

Manufacturer Narrative Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Model Number 102Event Date 09/28/2006Event Type Malfunction Event Description It was reported that device diagnostics resulted in high impedance (dc dc code - 7). It was reported that the patient experiences painful stimulation that started two weeks prior. The patient has not experienced any trauma to the neck area. The neurologist reviewed x-rays and reported that nothing unusual was noted. The patient was referred for surgery. The physician reported that the device was programmed off after observing the high impedance. The physician reported that x-rays would not be sent to manufacturer for review. Surgical intervention has not occurred to date.

Manufacturer Narrative Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description It was reported that the patient underwent surgery and that only the generator was replaced. It was reported that the generator was discarded after the surgery and would not be received for analysis. Attempts to obtain additional relevant information have been unsuccessful to date. It appears that the high impedance resolved with generator replacement since only the generator was replaced indicating a likely generator/lead connection problem.

Event Description Additional information was received indicating that the vns patient¿s generator replacement resolved reported high impedance. The replacement device was tested with the existing lead multiple times and showed lead impedance within normal limits.

Model Number 103Event Date 02/25/2014Event Type Injury Event Description Operative notes from the surgeon reported that because of intermittent painful stimulation, there was concern of a microfracture of the lead or a generator issue. The patient also believed something was wrong with the device. No further relevant information has been received to date.

Manufacturer Narrative The initial portion of the event description in supplemental mdr 2 was corrected as supplemental mdr 2 inadvertently implied that it was alleged that the motor vehicle accident had caused the painful stimulation in (b)(6) 2014 for which intervention had occurred.

Manufacturer Narrative Describe event or problem, corrected data: the initial manufacturer report inadvertently did not specify that the patient¿s fall may have ¿dislodged¿ the device again.

Manufacturer Narrative

Event Description It was reported that the vns patient fell off a horse on (b)(6) 2014. During an office visit the following day, the patient reported pain occurring with stimulation. The device was subsequently programmed off but the pain persisted. Diagnostic results revealed normal device function at the time. The patient underwent generator and lead replacement surgery due to pain on (b)(6) 2014. The patient's pain had resolved since the replacement surgery, which was performed as a precaution and for patient comfort. The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description The patient's mother reported that the patient first time the patient had experienced painful stimulation was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert. The vehicle landed on the passenger side and caused the patient to dangle from the seat belt. The mother noted that the painful didn't have painful stimulation again until (b)(6) 2014, which was already reported as when the patient fell off her horse, and the patient was instructed to tape the magnet over the generator to disable the device.

Event Description The neurologist also noted that the patient¿s fall may have ¿dislodged¿ the device again. It is unclear when the previous occurrence was as a previous report of painful stimulation subsided with device disablement. Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Review of the decoder data did not reveal any anomalies. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Abrasions were observed in various locations, possibly caused by wear. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Event Description The patient's mother reported that the patient was involved in a motor vehicle accident in (b)(6) 2013 where the car went off of the road and over a six foot culvert. The vehicle landed on the passenger side and caused the patient to dangle from the seat belt. The mother noted that the painful stimulation did not occur until (b)(6) 2014 and the patient was instructed to tape the magnet over the generator to disable the device. The following day, the patient was seen by the physician. The physician removed the magnet and the patient again experienced painful device stimulation. The device was programmed off for three days and when programmed back to on, the patient again experienced painful stimulation.

Event Description It was reported that the generator was replaced prophylactically and that the migration of the device was believed to be due to the trauma from the patient falling off of the porch. The increase in seizures was reported to be not related to vns. The patient was reported to be doing "fine" since generator replacement and no longer experiencing the reported events.

Event Description It was reported that the patient suffered a fall off of the front porch which resulted in injury to her left neck. The patient indicated that she began experiencing an increase in seizures. It was reported that the patient began experiencing painful stimulation the night of the fall after she felt something "snap" while laying in bed. It was reported that the patient also began experiencing pain in her chest around the generator and felt as if the generator had slipped down lower toward her breast. The patient was awaiting scheduled prophylactic battery replacement at the time of the fall; however, the physician wanted to get the patient to surgery sooner as a result of the events. The patient underwent generator replacement. It was reported that pre-operative device diagnostics were within normal limits (2323 ohms). The generator was replaced and diagnostics were again within normal limits (2048 ohms). It was reported that the explanting facility does not return explanted devices; therefore, no analysis can be performed. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description It was reported that the vns patient was experiencing pain on the left side of her neck with magnet mode stimulation while being able to tolerate normal mode stimulation. Changes to the patient¿s programmed settings were unsuccessful in resolving the pain. The patient had a surgical consultation on (b)(6) 2014 to plan interventions to preclude a serious injury and for patient comfort. No known surgical interventions have occurred to date.

Event Description It was reported that the neurologist and the surgeon indicated that the lead looks ok and they aren't going to do anything further.

Event Description It was reported that the patient is having a consult with the neurologist regarding the vns. Interrogation during consult showed that the generator has 50% battery and therefore there are no plans for surgery currently. Diagnostics were reported to be within normal limits.

Model Number 302-20Event Date 04/13/2014Event Type Injury Event Description It was reported on the implant card that the reason for lead replacement was a ¿lead discontinuity¿. It was reported that the hospital discards the explants and therefore cannot be returned for product analysis.

Event Description Clinic notes dated (b)(6) 2014 note that the patient was still having symptoms after generator settings changes. It was noted that the patient needs replacement of the lead to see if that will help with her symptoms and allow her to receive full vns therapy. It was noted that no other major changes have occurred in the patient's medical history. An implant card was received indicating that the patient underwent lead replacement on (b)(6) 2014. The explanted device has not been received for analysis to date.

Manufacturer Narrative Describe event or problem; corrected data: inadvertently did not include that the lead replacement was due to a lead discontinuity on follow-up report #1.

Manufacturer Narrative Review of the available programming and diagnostic history.

Event Description It was reported that the vns patient went to the er on (b)(6) 2014 due to painful erratic stimulation. The er physician and neurologist stated that the patient¿s generator may be at end of service. The patient had not felt stimulation for the past eight months. Before going to the er, the patient was on a swing and was hanging by her left arm. The patient began experiencing painful stimulation at 45 second intervals. The patient was also experiencing tightening in her chest and reported that her magnet was not working. The patient had to press the magnet extremely hard against her generator to disable her device. Taping the magnet over the generator was ineffective in disabling the device. The patient was uncertain if her generator had migrated. The patient was seen by her neurologist on (b)(6) 2014. The neurologist decreased the patient¿s device settings during the office visit. The neurologist noted that the patient¿s voice alteration had significantly increased with stimulation. The patient felt that stimulation was traveling up her ear and around her temple. The physician stated that the generator pocket may have expanded and the generator may have migrated causing the magnet to activate magnet mode stimulation instead of disabling the device. The patient¿s device was tested during the office visit and diagnostic results showed lead impedance within normal limits. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 but continued to have painful stimulation after surgery. The replacement device had been programmed on to the patient¿s previous device settings. A radiology report was received but did not observe any issues with the generator and lead. The patient was referred for lead replacement surgery. Lead replacement surgery has not occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 1. 77 years until eri = yes. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Model Number 101Event Date 03/01/2014Event Type Injury Event Description It was reported that the patient underwent prophylactic generator replacement. It was reported that preoperative and postoperative device diagnostics were within normal limits (dc dc code - 2). It was reported that the patient has not yet been seen for follow-up with the neurologist since the surgery. It was reported that the explanting facility discarded the explanted generator; therefore analysis cannot be performed.

Manufacturer Narrative Review of the available programming and diagnostic history.

Event Description Additional information was received stating that the vns patient had a big aura on (b)(6) 2014. The patient became light-headed and was diaphoretic. The patient swiped her magnet but it did not help her aura. The patient stated that her previous auras were similar but not back up to pre-vns baseline levels. The patient did not have any auras after (b)(6) 2014. The patient also reported that her vns stimulation was no longer as strong as it was in the past. The patient¿s pre-operative evaluations had been completed. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description It was reported that the vns patient was experiencing an increase in seizures and pain/tightening at her lead site for the month prior to her office visit on (b)(6) 2014. The patient¿s device was not at end of service and had normal lead impedance (dc dc 2). The neurologist stated that the generator battery was probably low and was causing the patient¿s issues. Until recently, the patient was seizure free since vns. The patient also recently began experiencing daily auras. The patient had a bump on her neck that appeared a month before the office visit. The neurologist stated that the lead may no longer be tied down. The patient did not experience any pain when the lead site was touched but intermittently when vns stimulation occurred. X-rays were taken but have not been provided to the manufacturer for further evaluation. The patient was referred for generator replacement surgery. No known surgical interventions have occurred to date. Clinic notes were received indicating that the patient¿s device had not been interrogated for the past ten years. The patient reported having a tingling feeling at the generator site and can still feel stimulation that sometimes caused her to have voice hoarseness. As the patient¿s auras were becoming more frequent, the patient¿s settings were increased. Review of the available programming and diagnostic history showed the last known device settings were from 04/11/2003.

Event Description Additional information was received indicating that the vns patient¿s pain and rash was noted on (b)(6) 2014. The neurologist stated that the patient was too thin and that the device was bothering her. The patient¿s device was disabled but the patient¿s issues did not resolve. The patient¿s will be explanted for patient comfort but no known surgical interventions have occurred to date.

Event Description Additional information was received. Clinic notes dated (b)(6) 2014 from surgery consult reported that the patient's generator was causing more pain and weakness than her previous device due to the size, which was worse if it was manipulated. The surgeon advised that the device was likely not the source of all of her pain and does not expect all of the pain to resolve after removal. No known surgical intervention has occurred to date.

Event Description It was reported that the patient has been complaining of painful stimulation and a rash at the generator site. The patient is going to see surgeon for device explant. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.

Model Number 302-20Event Date 05/22/2014Event Type Malfunction Manufacturer Narrative \device failure is suspected, but did not cause or contribute to a death.

Event Description It was reported that the vns patient was having painful stimulation and an increase in seizures. System diagnostic results revealed high impedance. The patient¿s device was subsequently programmed off. The patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. The patient was in a car accident a few years ago and reported having pain in his chest and neck. The patient¿s device showed normal device function after the car accident until his recent office visit where high impedance was observed. The patient had up to five seizures per day prior to vns. The patient was doing well with vns and was almost seizure free with vns.

Model Number 103Event Date 05/01/2014Event Type Malfunction Event Description It was reported that the patient was being referred for revision surgery due to an onset of painful stimulation for the past week. The physician believes that the generator is malfunctioning due to the painful stimulation at the generator pocket. It was reported that device diagnostics were within normal limits. The patient was scheduled for surgery. The patient underwent generator replacement. An implant card was received indicating that device diagnostics with the new generator attached to the existing lead were within normal limits (2350 ohms). The generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description Analysis of the returned generator was completed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Model Number 300-20Event Date 09/21/2010Event Type Injury Event Description Reporter indicated that a vns pt was unable to have the vns settings increased to therapeutic levels due to coughing, painful stimulation, and muscle twitching. The patient's seizures have increased slightly but are still below pre-vns baseline levels due to the vns settings not being therapeutic. Different vns settings were tried but the events have continued. No changes to the vns settings were made prior to when the events began. Prior to the pt being unable to tolerate the stimulation, she had a neck adjustment by a chiropractor, which may be contributing to the issues. X-rays were reviewed which did not note any anomalies. Surgery to replace the vns appears likely.

Event Description It was reported that the vns patient was having intolerable voice issues on an hourly basis. The patient¿s device was interrogated and found to be programmed to settings indicative of an interrupted system diagnostic test. The patient¿s device was tested during an office visit the previous day, but the system diagnostic test had to be interrupted because the test was too painful for the patient to tolerate.

Model Number 105Event Date 05/12/2014Event Type Malfunction Event Description It was reported by the patient that her device settings had changed on their own from 5 to 10. It is unclear which device settings she was referring to. The patient was experiencing erratic stimulation, pain with stimulation, coughing and voice alteration. The pain was reported to be unbearable at times. The pain occurred at her electrode site and travelled up the left side of her head and down to her shoulder. No known interventions have occurred to date.

Model Number 302-20Event Date 08/25/2009Event Type Injury Event Description It was reported that the patient underwent generator replacement. The lead was not replaced. Device diagnostics prior to and during surgery were within normal limits. It was reported that the explanting facility does not returned explanted devices for analysis.

Event Description On (b)(6) 2015 the patient reported that his vns has been turned off for about 5. 5 months because of ¿several problems¿. It was later reported that the patient has had his device for a while due to painful stimulation. The patient will be proceeding with explant of the vns device. Although surgery is likely, it has not occurred to date.

Event Description Initially, it was reported that the patient has experienced pain in the left jaw and teeth. The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth. The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging. The patient reported that there appears to be muscles twitching in his neck area. The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians. It was later reported that the patient would be referred to surgeon for full vns revision surgery. Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision. No additional relevant information has been received to date. No surgical intervention has been performed to date.

Manufacturer Narrative

Event Description It was reported that the patient was turned up that day from 1. 0ma to 1. 25ma. Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again. It only lasted a little bit. The physician stated that the patient is having the same pain in the jaw with the new generator. The patient used to be set at 1. 75ma, but now when they turn the current up to 1. 25ma the patient experiences instant pain when the device turns on. He also states that after a few hours of normal operation the pain gets worse. Settings are output=1-1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin. Diagnostics are ok; impedance=2213ohms. The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.

Manufacturer Narrative Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.

Event Description Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014. The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option. During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down. Additionally, a tie-down had been placed on the electrode coil on the nerve. No other tie downs were observed. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Model Number 103Event Date 04/22/2014Event Type Malfunction Event Description Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.

Event Description Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.

Event Description It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.

Event Description Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.

Event Description It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.

Event Description Additional information was received that the patient's generator could never get regulated correctly. It is suspected that the regulation of the device refers to titration. Available programming history for the generator was reviewed. The patient's device was disabled the day of explant. Diagnostics at that time were within normal limits. After implant of the device, it was titrated to 0. 25 ma and the output current was increased up to 1. 5 ma a few months later. However, the settings were reduced down and disabled shortly after.

Model Number 103Event Date 07/08/2014Event Type Injury Event Description Additional information was received that the patient's painful stimulation and tingling began reoccurring in the neck and chest on (b)(6) 2015 despite no abnormal or strenuous activity by the patient. The vns device was interrogated and two diagnostic tests were performed which showed normal results. The generator was disabled. At first, the patient stated that she still felt stimulation, but after she was told that the device was off, then she said she couldn¿t feel it anymore. The patient's neurologist says that it could be psychosomatic symptoms. X-rays were taken but the radiologist stated there was no change from the previous x-rays in (b)(6). The device was thus temporarily disabled with magnet mode left enabled. Clinic notes were received from the appointment which confirmed the allegation that the patient was having pain in her left neck and left chest and that the device was disabled. It was also stated that these patient adverse events are similar to the pain event reported in mfr. Report # 1644487-2011-02585. Additional clinic notes stated that diagnostics were taken again and were within normal limits. The diagnostic tests reportedly caused significant discomfort immediately and resolved as the device turned off. The referring physician suspected that perhaps there is conduction of stimulation to surrounding tissues. No known surgical interventions have occurred to date.

Event Description Additional information was received via implant card that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to the painful stimulation. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description It was reported that the vns patient was having some breakthrough myoclonic seizures while previously being seizure free. The patient was also experiencing a tingling sensation but was unable to feel magnet mode stimulation when she swiped her magnet. The patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device settings were increased, but the patient reportedly did not feel stimulation in the same way as before and began having pain in her left arm with stimulation. The neurologist decreased the patient¿s device settings and the patient was reported to be doing well. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block; however, this could not be confirmed as the pin was not clearly shown to pass all the way through the connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the reported events remains unknown. No known surgical interventions have occurred to date.

Event Description It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to end of service. Additionally, the patient was having some discomfort when system diagnostic tests were performed. Surgery was performed for patient comfort and not to preclude a serious injury. The explanted generator was returned to the manufacturer for analysis. An open can measurement of the battery voltage determined that the generator battery was depleted. The end of service condition was the result of expected battery depletion based on the battery life calculation. Supply current pulsing and supply current 1ma were out-of-specification. Analysis indicated that during manufacture of the generator, the r35 resistor (a selectable value resistor) could have been more optimally chosen. A lower value resistor would have more suitably centered the currents within their limits. After r35 was optimally reselected, the device performed according to functional specifications. The out-of-specification supply current pulsing could potentially be a contributing factor to the end of service condition; however, results of the battery longevity calculation indicated that the end-of-service condition was an expected event. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Model Number 102Event Date 06/01/2014Event Type Injury Event Description Additional information was received that the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

Manufacturer Narrative

Event Description It was reported that the patient has recently felt erratic stimulation. The patient reported that the device stimulation can be strong at times and that he feels short bursts of strong stimulation. It was reported that the patient experiences pain in the neck area. Interrogation of the generator showed the device was not at end of service. It was reported that the patient was referred for surgery. Clinic notes dated (b)(6) 2014, note that the patient is having occasional sharp electric pains in the generator pocket or his neck. It was noted that the physician recommends having the generator replaced as he thinks this might be the problem. No known surgical intervention has been performed to date.

Event Description Additional information was received that the patient had a generator replacement. Attempt for product return have been unsuccessful.

Event Description Additional information was received that product analysis was completed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts for additional information have been unsuccessful.

Event Description Additional information was received that indicated the painful and erratic stimulation was first noticed 6/2014. The generator replacement was done for patient comfort it is unknown how the patient is doing since generator replacement. There was no manipulation or trauma or contributory programming or medication changes that caused or contributed to the events.

Event Description Clinic notes were received indicating that the vns patient was experiencing an increase in seizures in (b)(6) 2013. The patient¿s device settings were increased during an office visit on (b)(6) 2013 and the patient subsequently developed throat pain and voice hoarseness. The patient¿s device settings were adjusted on (b)(6) 2013. The patient did not have any seizures but continued to have painful stimulation. On (b)(6) 2013, the patient¿s device settings were increased and the patient reported no pain but persistent voice hoarseness. Follow-up revealed that diagnostic results at the time showed normal device function. The patient¿s seizures were above pre-vns baseline levels, but not all of the patient¿s seizures types increased. No changes occurred to the patient¿s medications or device settings which may have caused or contributed to the event.

Model Number 102Event Date 07/28/2014Event Type Injury Event Description It was reported that the vns patient was referred for surgery during an office visit on (b)(6) 2014 due to lead protrusion and painful stimulation. The patient¿s device was subsequently disabled. Patient manipulation or trauma is not believed to have caused or contributed to the lead protrusion. Diagnostic results showed normal device function at the time. Follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014 due to painful stimulation and eri. The lead protrusion was determined to be minor and did not require revision surgery. The patient¿s device was programmed on at a follow-up office visit after surgery. The patient no longer had complaints of lead protrusion or painful stimulation. The explanted generator has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description Additional information was received stating that the vns patient continued to experiencing painful stimulation in her left arm. The patient had been experiencing an increase in seizures and pseudo-seizures since the device had been disabled due to the painful stimulation. The lead impedance was within normal limits. X-rays were taken and reported by the physician to be unremarkable. X-rays were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. The patient was referred for surgery for the painful stimulation but no known surgical interventions have occurred to date.

Event Description Additional information was received stating that the patient underwent a lead revision surgery (b)(6) 2015. The explanted lead was discarded and thus will not be returning to the manufacturer for analysis.

Event Description It was reported that the patient was unable to turn off the vns with any of the magnets she has. The vns was later disabled. The patient reported that she tried to disable her generator because of severe pain at the time of stimulation. She has had the magnets since 2006, when she was first implanted. The physician turned the 2. 5ma down to output of 2. 25ma, then 2. 0ma, 1. 75ma, and then 0ma and back to 0. 25ma. The planned intervention is for the patient to undergo a generator replacement surgery. The physician stated that the magnet did cause/trigger violent coughing episodes upon application. System diagnostics were performed and no abnormalities were noted and the device was not near eos. No causal or contributory programming changes preceded the onset of the painful stimulation. The surgery was planned to preclude a serious injury, per the physician. The physician further stated that the patient¿s magnet mode stimulation is always off unless it is ¿spontaneously switching¿. The patient later clarified that she had begun to experience painful stimulation when she received her original implant in (b)(6) 2006. The anatomical location of the painful stimulation comes from the vagus nerve, up and down her neck, during stimulation. There has been no trauma to the left side or the vagus nerve. The patient has been using new magnets that she received a few weeks ago. The physician stated that he could not provide clarification on his statement that the device may be ¿spontaneously switching¿; he stated that he has never activated magnet current and no other physician programs the device. He stated that the ¿device is faulty no matter what¿. The physician indicated that the patient was slowly titrated up after implant in order to allow for accommodation to the stimulation. The physician later stated that the patient underwent a cervical rhizotomy soon after the issue began with the generator. The patient stated that she always has had pain with stimulation. She said it is at a low level and has never bothered her. She stated that her current generator has caused her different side effects than with her previous ones. The physician interrogated it at every visit to make sure the generator is functioning at the levels, he has set. She stated that at the end of (b)(6) 204, she suddenly had intense pain. She immediately put the magnet in place and instantly began to cough violently and her throat constricted so much she couldn¿t breathe. The physician set up an emergency visit for her to see him and at that visit she demonstrated what happened when she put the magnet in place over the generator. She again when into a violent coughing attack and her throat constricted as it had when she tried to use it in june. The physician quickly lowered the current down and got the same response. After doing so, a couple of times, he turned the generator off completely. After a bit, he turned the generator back on to 0. 25ma. The physician instructed her to put the magnet in place as he increased the output to 0. 25ma and interrogated it at the same time. The magnet worked normally and the diagnostics of the generator showed it functioning normally as well. The patient clarified that she is fully aware how to use the magnet. The patient stated that before the event in june she had just seen her physician two weeks prior, when her device was interrogated, and the physician did not change anything at that visit. The patient underwent generator replacement on (b)(6) 2014. The explanted generator has not been returned for product analysis to date.

Event Description On (b)(4) 2014 the explanted generator was returned for product analysis. Product analysis was completed on the generator on (b)(4) 2014. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. No magnet parameters (as received or programming history) available for this generator, magnet current was set to 0. 50ma. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported allegations against the generator were not duplicated in the product analysis lab. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description The patient's magnet was tested with the new generator, and the physician reported that it was working well. It is also noted that the as-received explanted generator frequency parameter was set to 1hz. Per manufacturer labeling, frequencies programmed to <10hz do not ramp and cause excessive battery drain regardless of output current.

Event Description On (b)(6) 2014 the physician reported that the patient has not yet tried the magnet with her new generator but that they will test it at the next visit.

Manufacturer Narrative Age at time of event, corrected data: the initial report inadvertently reported the incorrect date.